Virginia Clinical Research, Inc.

SAHARA Meets Study Endpoints, Demonstrating Underarm Sweating Significantly Reduced Following Three-Minute In-Office Treatment NASHVILLE, Tenn., March 18, 2023 /PRNewswire/ -- Candesant Biomedical ("Candesant"), a private medical device company focused on the development and commercialization of non-invasive treatments for hyperhidrosis or excessive sweating, today announced findings from its pivotal clinical study of its investigational sweat control patch, the first three-minute patch for the significant reduction of excessive underarm sweating in patients with primary axillary hyperhidrosis. The findings from SAHARA, a randomized, double-blind, sham-controlled, multicenter trial, were described in a late-breaking oral presentation at the 2023 annual meeting of the American Academy of Dermatology. The study showed the sweat control patch met key efficacy endpoints and was well tolerated, with no serious adverse events reported at any time by any study participant.1 "The results of SAHARA are exciting because they demonstrate consistent, statistically significant, and clinically meaningful improvements across the measured hyperhidrosis parameters: Hyperhidrosis Disease Severity Scale scores, sweat production, and quality of life," said SAHARA study presenter and investigator David Pariser, MD, FACP, FAAD, professor of the Eastern Virginia Medical School Department of Dermatology, cofounder of Virginia Clinical Research, Inc., past president of the American Academy of Dermatology, and founding member of the International Hyperhidrosis Society. "If the sweat control patch is cleared by the U.S. Food and Drug Administration, it could be a groundbreaking option for both providers and patients and has the potential to set a new standard of care for the treatment of primary axillary hyperhidrosis, or excessive underarm sweating." Candesant Founder and CEO Niquette Hunt said, "We are thrilled with the results of our SAHARA pivotal trial and believe our investigational patch, if cleared, has the potential to help millions of people dealing with the physical, emotional, financial, and aesthetic impacts of excessive underarm sweating." Novel Mechanism of Action Currently under review by the U.S. Food and Drug Administration, the investigational sweat control patch is a single-use disposable patch applied by a health care provider and consists of a sodium sheet with an adhesive overlay. Its mechanism of action utilizes Candesant's patented SweatTech™ technology, which is based on the scientific principle that heat is generated when sodium comes in contact with water in sweat. The thermal energy created by the sweat control patch is precisely localized, microtargeting sweat glands to significantly reduce sweat production. Candesant's investigational sweat control patch is the first clinical application to harness and target this well-established scientific principle, and is the only patented medical device based on it.2,3 More About SAHARA Study and Findings SAHARA study participants were adults with baseline Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 (with 4 being the highest score), indicating their sweating frequently or always interferes with their daily activities.4 A total of 110 participants were randomly assigned to bilateral treatment with the sweat control patch or a sham patch for up to three minutes for each underarm. Safety was evaluated for all enrolled participants and efficacy for those who met protocol criteria. Assessments were made weekly for 12 weeks post-treatment, with responders followed for up to 24 weeks post-treatment. The main findings related to excessive underarm sweating at four weeks include: Primary endpoint: 64% of treated participants vs. 44% of sham-treated participants improved HDSS scores to 1 or 2, indicating their sweating never or sometimes interferes with their daily activities (p=0.0332) 43% of treated participants vs. 16% of sham-treated participants achieved a 2-point or greater improvement in HDSS (p=0.0107) 60% of treated participants vs. 33% of sham-treated participants showed a 50% or greater reduction in their amount of sweat as measured by gravimetric sweat production (GSP) Treated participants had greater mean reductions in GSP than sham-treated participants: 57 mg in 5 minutes vs. 18 mg in 5 minutes, respectively (p=0.0036) Treated participants reported significantly greater reductions in sweat level of Bother (5-point scale) than sham-treated participants: 1.52 points vs. 0.61 points, respectively (p=0.0005) Treated participants reported significantly greater reductions in sweat level of Impact on daily activities (5-point scale) than sham-treated participants: 1.44 points vs. 0.57 points, respectively (p=0.0004) No serious adverse events were reported at any time for any study participant. All reported adverse events for participants treated with the sweat control patch were mild to moderate and most resolved within two weeks. About Hyperhidrosis Approximately 4.8% of Americans (15.3 million) report having hyperhidrosis, and about two-thirds of them (~10 million) experience sweating under the arms, the most frequently reported site.5 However, many hyperhidrosis experts believe these numbers are an underestimation because the condition is underreported and underdiagnosed.5 In fact, the International Hyperhidrosis Society (IHHS) estimates one in three U.S. adults (85.2 million6,7) are bothered by their excessive underarm sweating.6 Among consumers seeking aesthetic treatments, a recent survey by the American Society for Dermatologic Surgery (ASDS) found nearly 6 out of 10 (58%) stated they are most bothered by excessive sweating.8 To find out more about the sweat control patch, visit . About Candesant Biomedical Candesant Biomedical is a private medical device company focused on the development of non-invasive treatments for hyperhidrosis or excessive sweating. Candesant has developed the first investigational sweat control patch utilizing its patented SweatTech technology for the treatment of primary axillary hyperhidrosis or excessive underarm sweating. The company is also exploring future potential indications, including facial hyperhidrosis, palmar hyperhidrosis, and plantar hyperhidrosis. To learn more about Candesant, visit . "Candesant" is a registered trademarks of Candesant Biomedical. Media Contact Suzanne Haber TogoRun 917-531-6953 [email protected] References 1 Glaser DA, Green L, Kaminer M, Smith S, Pariser D. Outcomes from the SAHARA Clinical Study on the TAT Patch for Excessive Axillary Sweating or Primary Axillary Hyperhidrosis. Late-breaking oral presentation at: American Academy of Dermatology annual meeting; March 17-21 (presented March 18, 10:10 am CT), 2023; New Orleans, Louisiana. 2 Kaufman J, Green JB, Cazzaniga A, Canty DJ, Tims E, Waugh J. A Pilot Study of the Safety and Effectiveness of a Novel Device in Subjects With Axillary Hyperhidrosis. Dermatol Surg. 2022;48(11):1220-1225. doi:10.1097/DSS.0000000000003598 3 Waugh JM, Elkins C, Rhee H, inventors. Candesant Biomedical, Inc., assignee. Medical devices for generating heat and methods of treatment using same. U.S Patent 2021;11:425. 4 Solish N, Bertucci V, Dansereau A, et al. A comprehensive approach to the recognition, diagnosis, and severity-based treatment of focal hyperhidrosis: recommendations of the Canadian Hyperhidrosis Advisory Committee. Dermatol Surg. 2007;33(8):908-923. Doi:10.1111/j.1524-4725.2007.33192.x 5 Doolittle J, Walker P, Mills T, et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 308, 743–749 (2016). . 6 International Hyperhidrosis Society. IHHS sweat survey reveals many are suffering in silence. Sweat Solutions. September-October 2008: 1-4. 7 Ogunwole SU, Rabe MA, Roberts AW, Caplan Z. Population Under Age 18 Declined Last Decade. August 12, 2021. Available: . Accessed Mar 7, 2023. 8 American Society for Dermatologic Surgery (ASDS). 2021 Consumer Survey on Cosmetic Dermatologic Procedures. Press Release, June 20, 2022. Available: . Accessed Feb 10, 2023. SOURCE Candesant Biomedical, Inc.

NASHVILLE, Tenn., March 9, 2023 /PRNewswire/ -- Candesant Biomedical ("Candesant"), a private medical device company focused on the development of non-invasive treatments for hyperhidrosis or excessive sweating, today announced the acceptance of its pivotal SAHARA clinical trial data for its investigational targeted alkali thermolysis (TAT) Patch in a late-breaking oral presentation at the 2023 annual meeting of the American Academy of Dermatology (AAD), on March 18, 2023 in New Orleans, LA. Details of the presentation are as follows: Title: Outcomes from the SAHARA Clinical Study on the TAT Patch for Excessive Axillary Sweating or Primary Axillary Hyperhidrosis Session: Late-Breaking Research Session 1 (S025) Date/Time: Saturday, March 18, at 10:10 am CT Location: New Orleans Ernest E. Morial Convention Center Theater B The oral presentation will be given by Dr. David Pariser, Eastern Virginia Medical School and Virginia Clinical Research, Inc., and one of the Investigators for the SAHARA trial. "We are delighted our SAHARA pivotal trial data was selected as a late-breaking oral presentation at this year's AAD meeting," said Niquette Hunt, Founder and CEO of Candesant. "Excessive underarm sweating impacts millions of people physically, emotionally, and aesthetically. If FDA cleared, our investigational Patch will provide an important treatment option for patients seeking a non-invasive approach for control of primary axillary hyperhidrosis." About Candesant's Investigational Patch Currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of primary axillary hyperhidrosis or excessive underarm sweating, Candesant's investigational non-invasive Patch is applied to the underarm by a health care provider during an in-office treatment. The Patch is activated when the water in sweat contacts the Patch's sodium sheet. The sodium in the Patch creates precisely localized thermal energy, microtargeting sweat glands and reducing excessive underarm sweat production. The Patch stays on for up to three minutes on each underarm, is single-use, and disposed of after the treatment. About Hyperhidrosis or Excessive Sweating Approximately 4.8% of Americans (15.3 million) report having hyperhidrosis, and about two-thirds of them (~10 million) experience sweating under the arms, the most frequently reported site.1 However, many hyperhidrosis experts believe these numbers are an underestimation because the condition is underreported and underdiagnosed1. In fact, the International Hyperhidrosis Society (IHHS) estimates one in three U.S. adults (85.2 million2,3) have excessive underarm sweating.4 About Candesant Biomedical Candesant Biomedical is a private medical device company focused on the development of non-invasive treatments for hyperhidrosis or excessive sweating. Candesant's investigational Patch is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of primary axillary hyperhidrosis or excessive underarm sweating. The Patch utilizes Candesant's patented SweatTech "TAT" (targeted alkali thermolysis) technology. The company is also exploring future potential indications, including facial hyperhidrosis, palmar hyperhidrosis, and plantar hyperhidrosis. To learn more about Candesant, visit . Doolittle J, Walker P, Mills T, et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 308, 743–749 (2016). . International Hyperhidrosis Society. IHHS sweat survey reveals many are suffering in silence. Sweat Solutions. September-October 2008: 1-4. Ogunwole SU, Rabe MA, Roberts AW, Caplan Z. Population Under Age 18 Declined Last Decade. August 12, 2021. Available: Accessed Mar 7, 2023. International Hyperhidrosis Society. IHHS sweat survey reveals many are suffering in silence. Sweat Solutions. September-October 2008: 1-4.